Field study

Introduction

Industry sponsored study

9795 diabetics not on lipid-lowering therapy

micronized fenofibrate 200 mg daily vs placebo

median 5 years of follow-up

primary outcome of first myocardial infarction or coronary death

Results:

• fenofibrate group had a non-significant reduction in primary outcome
• fenofibrate group had a significant 11% relative reduction in total cardiovascular disease & a 21% reduction in coronary revascularizations
• fenofibrate group had a non-significant increase in coronary heart disease mortality
• fenofibrate did not significantly reduce total cardiovascular events in patients with previous CVD or in those aged 65 or older
• fenofibrate group had significantly less progression of albuminuria & fewer retinal laser procedures
• amputations occurred significantly less often in the fenofibrate group (0.9% vs. 1.4%), including:
  • below-ankle amputations (0.6% vs. 1.1%)
  • below-ankle amputations without concomitant large-vessel disease (0.4% vs. 0.7%)
  • no between-group differences were noted in above-ankle amputations
  • overall number needed to treat to prevent one amputation is 197, but only 25 for patients with previous foot ulcers & albuminuria
• fenofibrate group had significant increases in pancreatitis & pulmonary embolism
• all-cause mortality was higher in the fibrate group than the placebo group (7.3% vs 6.6%)
• more frequent initiation of statin therapy in patients allocated placebo may confound interpretation

More general terms

• clinical trial